A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab in Patients with Multiple Sclerosis
This study is for people with Multiple Sclerosis (MS) who are currently using or considering a treatment called Ocrevus. Normally, Ocrevus is given through a drip into a vein (intravenously). This trial is testing if giving Ocrevus as a shot under the skin (subcutaneously) works just as well as the usual drip, and if it's safe. We want to see if the new way of giving the medicine delivers the same amount of drug to your body. Doctors will also check for changes in MS activity using brain scans (MRIs) and look for any side effects. The aim is to find a treatment method that is effective and potentially more convenient for patients.
At a glance
What is this study about?
This study is focused on people living with Multiple Sclerosis, often shortened to MS. MS is a condition that affects your brain and spinal cord, leading to a range of symptoms. There's a treatment called Ocrevus that many people with MS use, which is currently given through a drip into a vein, usually at a hospital or clinic. This can take a few hours and requires regular visits.
What this study is trying to find out is whether Ocrevus can be given in a different way – as a shot under the skin, similar to how some people might give themselves an insulin shot. This new way of giving the medicine is called "subcutaneous" administration. The main goal is to see if giving Ocrevus as a shot ensures that your body receives the same amount of the medicine as it would with the usual drip. If it does, and if it’s safe, it could potentially offer a more convenient option for patients in the future.
To make sure the new method is just as good, researchers will be carefully comparing it to the standard drip. They will measure the levels of the medicine in your blood and watch for any changes in your MS using brain scans (MRIs). They'll also be keeping a close eye on any side effects to make sure the new method is safe. Ultimately, this research aims to improve how people with MS receive their treatment, potentially making it easier and more accessible.
Key takeaways
- This study explores a new way to give Ocrevus for MS.
- It compares a shot under the skin to the current IV drip.
- The goal is to find a more convenient, but equally effective and safe, treatment option.
- Participation involves regular clinic visits, blood tests, and MRI scans.
- You will be closely monitored for treatment effects and side effects.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old. People of all genders are welcome to potentially participate in the study.
Beyond these basic requirements, there will be more specific health checks and criteria that the study doctors will need to review. For example, they'll check your medical history to make sure the study treatment is suitable and safe for you, and that you meet all the necessary health standards for the trial. It's really important to discuss your full medical history with the study team.
The research team will go through all the detailed requirements with you to see if this study is a good fit. They'll make sure you understand everything before you make any decisions.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with Multiple Sclerosis?
- Are you able to attend regular clinic appointments and MRI scans?
- Are you willing to potentially receive Ocrevus as a shot under the skin?
What does participation involve?
If you decide to take part in this study, you'll be assigned to receive Ocrevus either in the usual way (through a drip into a vein) or as a new shot under the skin. You won't get to choose which method you receive. The study will involve regular visits to the clinic or hospital over a period of time. At these visits, you'll have blood tests to measure the amount of drug in your system and to check your general health, including vital signs like blood pressure.
You'll also have several brain scans (MRIs) at different times throughout the study to see how your MS is responding to the treatment. The research team will carefully monitor you for any side effects and ask about your health at each visit. The total duration of your participation will depend on the study's design, but it will involve multiple appointments over several months, possibly up to 96 weeks (about a year and a half). You will receive the study medication as part of your participation.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedItaly
Common questions
What is the main goal of this study?
The main goal is to see if giving Ocrevus as a shot under the skin works just as well and is as safe as giving it through a drip into a vein for people with MS.
Will I get to choose how I receive Ocrevus?
No, in this study, participants are randomly assigned to either receive the usual drip or the new shot, meaning you won't get to choose.
What kind of tests will I have?
You'll have blood tests to check drug levels and general health, and brain scans (MRIs) to monitor your MS.
How long will I be in the study?
The study will involve multiple visits over several months, potentially up to 96 weeks (about a year and a half).
What if I change my mind about participating?
You have the right to leave the study at any time, for any reason, and it won't affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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